FDA Eases Expiration Date Requirements for Repackaged Solid Oral Dosage Drugs

Sterial Packaging The form-fill-seal technology blow-fill-seal technology Pre-filled syringe system Lyophilization Slide 2: Polymer granules are continuously fed to a machine hopper through screw extruder. Then it is extruded through die and pin set to form an open ended tube of molten polymer known as parison. A mould set in two halves then moves over to the parison and closes around it. Molding is facilitated by vacuum The molded plastic is severed from the continuously extruding parison by a hot-knife, and is then shuttled within the mold set to the filling parison. Generally cutting of parison with hot-knife is associated with a problem of generation of particulate matter which is overcome by following technique.

2018 Minnesota Statutes

Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be? The auto-calibration feature of a balance may not be relied upon to the exclusion of an external performance. For a scale with a built-in auto-calibrator, we recommend that external performance checks be performed on a periodic basis, but less frequently as compared to a scale without this feature.

The frequency of performance checks depends on the frequency of use of the scale and the criticality and tolerance of the process or analytical step. Note that all batches of a product manufactured between two successive verifications would be affected should the check of the auto-calibrator reveal a problem.

A growing number of hospitals have implemented a unit dose dispensing system, with an prepared drugs significantly increases the patient’s safety, as the human controls are not without Expiration Dating of Unit Dose Repackaged Drugs, sec. ,FDA, 2/1/84, revised.

A unit dose package makes the administration of drugs more convenient and less susceptible to errors such as administering too much or too little of the drug at one time. Residents of the facility are free to obtain drugs from the pharmacy of their choice, however, and pharmacies that are not under contract with the facility often do not dispense drugs in a unit dose package.

Some of ASCP’s members have been asked by longterm care facilities with which they contract to repackage prescription drugs dispensed by other pharmacies to facility residents in a loose oral dosage format. These ASCP members are concerned that repackaging drugs in this circumstance is inappropriate under state and federal law guidelines, or that it may subject them to enhanced professional liability.

We are in agreement with the concerns expressed by ASCP members that repackaging previously dispensed drugs into unit dose containers may be inappropriate under the FDA’s Compliance Policy Guide for repackaging and return of unused medications, as well as various state laws that regulate the practice of pharmacy. Moreover, we believe that such repackaging raises liability concerns for pharmacies.

Guidance Document: Labelling of Pharmaceutical Drugs for Human Use

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An official dosage form is required to bear on its label an expiration date assigned for the particular formulation and package of the article. This date limits the time during which the product may be dispensed or used. However, under no circumstance should the repackaged pharmaceutical preparation’s expiration date exceed the original manufacturer’s expiration date.

It is necessary, therefore, that other precautions be taken by the dispenser to preserve the strength, quality, and purity of drugs that are repackaged for ultimate distribution or sale to patients. The following guidelines and requirements are applicable where official dosage forms are repackaged into single-unit or unit-dose containers or mnemonic packs for dispensing pursuant to prescription.

Repackaged dosage forms must bear on their labels expiration dates as determined from information in the product labeling see Preservation, Packaging, Storage, and Labeling section of the General Notices and Requirements. Each single-unit or unit-dose container bears a separate label, unless the device holding the unit-dose form does not allow for the removal or separation of the intact single-unit or unit-dose container therefrom.

A refrigerator or freezer shall not be considered to be a humidity-controlled environment. Drugs that are to be stored at a cold temperature in a refrigerator or freezer must be protected during storage in the refrigerator or freezer. An outer container may be necessary for such protection; it is recommended that the drug monograph be referenced for storage.


For the purposes of this section, the following terms have the meanings given them unless otherwise provided by text: Authorization to administer and repackage drugs. The contract pharmacy shall notify the long-term care facility whenever medications have been dispensed according to this subdivision and must certify that the repackaging and dispensing has been done in accordance with this subdivision.

For each drug repackaged by a contract pharmacy under this section, the contract pharmacy shall maintain a record for at least two years of the following information:

Once a drug product is removed from the manufacturer’s container and is repackaged into a different container (e.g., into an amber pharmacy bottle, unit dose packages for hospitals), the USP specifies that a beyond-use date be placed on the label of the new packaging; this is the date after which a drug product should not be used.

This practice protects patients from life-threatening infections that occur when medications get contaminated from unsafe use. Concerns have been raised about whether these guidelines and related policies contribute to drug shortages and increased medical costs to healthcare providers. CDC recognizes the problem of drug shortages; however, such shortages are a result of manufacturing, shipping, and other issues unrelated to the above guidelines http: These outbreaks cause extensive harm to patients, and they are associated with significant healthcare and legal expenses.

It is imperative that drug shortages and drug waste concerns are dealt with appropriately and do not lead to unsafe medical practices that impose increased disease risk on patients. These medications typically lack antimicrobial preservatives and can become contaminated and serve as a source of infection when they are used inappropriately.

cGMP: Laboratory Controls – Question & Answer?

For VCU Medical Center, a bed hospital in Richmond, Virginia, outsourcing some of our packaging needs presented an efficient and cost-effective solution to managing our packaging workload. We decided to outsource repackaging of several oral liquids not available in unit dose form since packaging these items onsite was labor intensive and time consuming. Inventory Management Challenges While outsourcing provides numerous benefits, it also can pose some inventory management challenges.

Anticipating potential issues and implementing a solid system to manage this process will help ensure optimal inventory. In order to accommodate this change in our unit dose packaging system, we had to change our ordering scheme.

Stability considerations of Dosage forms Stability: is defined as the extent to which a product retains, within specified limits, and throughout its period of storage and use (shelf-life), the same properties and characteristics that it.

This general chapter contains minimum standards to be used as a guideline for repackaging practices. This guideline is not intended to replace or supplant the requirements of regulatory agencies. Repackaging preparations into unit-dose configurations is an important aspect of pharmaceutical care and of optimization of patient compliance. For purposes of this chapter, there are two types of repackaging: In addition, dispensers may prepare limited quantities in anticipation of a prescription or medication order from a physician.

Dispensers are governed by the board of pharmacy of the individual state. The terms dispenser and pharmacy are used interchangeably. Repackaging firms repackage preparations for distribution e. Distribution is not patient specific in that there are no prescriptions. Various packaging materials are used to create blisters that are tailored to provide optimum performance.

The blister container consists of two components: Because of the variety of blister films available, film selection should be based upon the degree of protection required.

Guidance : expiration dating of unit-dose repackaged drugs, compliance policy guide.

Hold the specimen at for 1 minute. Quickly cool the specimen to room temperature, and reheat it to at a heating rate of about 5 per minute. Quickly cool the specimen to room temperature, and reheat it to at a heating rate of about 10 per minute. Apply the closure firmly and uniformly each time the bottle is closed. Weigh each empty bottle and its closure. Record the weight of each bottle and its closure, and determine the average bottle volume, in L, taken by the following formula:

Expiration dating for nonsterile drugs repackaged by the pharmacy into single unit, unit dose or unit of issue packages shall meet the following conditions: i.

This chapter does not apply to pharmacists engaged in dispensing prescription drugs in accordance with state practice of pharmacy. The pharmacist needs to apply and other beyond-use date references in the subsection Expiration Date and Beyond-Use Date in the Labeling section under General Notices and Requirements. Repackaging firms repackage preparations for distribution e. Distribution is not patient-specific in that there are no prescriptions. These containers should meet all of the applicable requirements in this chapter.

A contract packager does not take ownership from the manufacturer and generally receives the assigned expiration date from the contractor. Where no specific storage conditions are specified, the product must be maintained at controlled room temperature and in a dry place during the repackaging process, including storage. Nitroglycerin Sublingual Tablets or any other drug product known to have stability problems should not be repackaged. This would include any drug known to be oxygen-sensitive or one that exhibits extreme moisture or light sensitivity.

In deciding whether a particular drug product is suitable for repackaging, the repackager should take into consideration any available information from the manufacturer, published literature, the USP, and the FDA. Documentation must be maintained to demonstrate that the preceding criteria are met. When no specific storage conditions are specified, the product should be maintained at controlled room temperature and in a dry place during repackaging operations.

Expiration Dating of Unit Dose Repackaged Drugs

USP Class A 1. Made from quality raw materials providing both an attractive appearance and durability. Our packaging materials meet USP requirements for a class. USP 40 Physical Tests. The desiccant is silica gel molded in a form to fit the size and shape of the blister. Regulations for Flexible Pharmaceutical Packaging.

Sec. Expiration Dating of Unit Dose Repackaged Drugs (CPG b) BACKGROUND: Unit dose packaging systems are currently widespread in health care. Some unit dose containers are available directly from manufacturers and repackagers, and some drugs are packaged into unit dose containers by hospital/community pharmacies or shared service.

For A and B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions? Do you know the Federal and State laws you are required to follow? Do you have the right enabling documentation procedures, policies, records, etc.

Are you organized effectively to execute the requirements? Do you have the right people in place? Are they effectively trained and can you produce the training records? Is the role of your pharmacist-in-charge and your Quality Unit well defined roles, responsibilities, and authorities? Do you have the right infrastructure people, facilities, computer systems, space, etc.

BUSTERDOSE – A Complete System for the Management of Unit-dose Drugs and Consumables